Site Quality Head, R&D

Job Title: Site Quality Head, R&D

Location: Swiftwater, PA

Provides site leadership and direction to R&D for quality and compliance systems in order that quality practices are developed and maintained for clinical testing laboratories in GCI and for early phase manufacture, testing, and release of clinical trial materials performed internally at Swiftwater or with external CMO/CRO partners.

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale – and shape the future of immunization.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Directs a small team of quality professionals to ensure effective GxP compliance programs are in place in site Vaccines R&D functions, based on Global R&D Quality strategy, and in accordance to applicable regulations and company standards. Accountable for unit performance based on company, quality and project objectives, and for development of an Annual Quality Plan based on site performance metrics. Responsible to promote a quality culture mindset that ensures compliance and drives quality continuous improvements.

Represents Vaccines R&D Quality Swiftwater on the R&D Quality Leadership Team to establish priorities, define initiatives for improvement, develop and manage the budget. Acts as a subject matter expert for local R&D functions on quality-related topics.

• Provide direction, guidance, and education on quality and compliance (GLP, GCP, GMP) to ensure adherence to regulations and Sanofi policies
• Serve as primary liaison with Quality Risk Manager for site risk-mapping and remediation
• Collaborate with global R&D Quality and local Manufacturing & Supply Quality

• Manage and coordinate the Swiftwater R&D Quality team's activities and priorities
• Establish performance expectations, provide regular feedback, and define skill enhancement programs
• Distribute workload to ensure timely deliverables
• Provide quality support and resources to R&D senior management

• Lead site inspection readiness for internal, external, and third-party audits
• Ensure quality oversight of third-party suppliers and subcontractors, including quality agreements
• Serve as subject matter expert during inspections, defending quality programs and providing timely responses to audit observations

• Support local and global quality system improvement initiatives
• Report site quality metrics to senior management across R&D functions
• Define annual evaluation programs based on quality indicators and metrics
• Support corrective action development and follow-up

• Implement standardized processes and tools at the local level
• Act as "Voice of Customer" and provide feedback on roadblocks
• Share inspection experiences, best practices, and propose process improvements
• Contribute to CoP roadmap objectives

• Oversee compliance with employment, health, and safety legislation
• Respond promptly to safety concerns/incidents and support investigations
• Complete appropriate documentation in a timely manner

• Manage quality and compliance for clinical trial material (CTM) manufacturing and testing, plus clinical sample laboratory oversight
• Stay current with changing regulatory environment and apply quality risk management approaches
• Defend programs during audits/inspections in a competent and convincing manner
• Requires strong organization, autonomy, decision-making, and communication skills
• Interact with colleagues across multiple international sites
• Local accountability with potential global impact on R&D departments
• Minimal travel required for audits…